Failure Mode & Effects Analysis: A Management Primer

July, 2001
Michael Strum
HP-ESTC Product Reliability & Test Team

Purpose
To identify and plan responses to the most critical risks to cost, schedule, and customer satisfaction in a
systematic approach that guides decision-making when creating a new product or process. The goal is to
resolve potential problems before they occur.

Process Description
FMEA is structured process of potential failure mode recognition, prioritization, and action definition
performed through the inputs of a multi-disciplined team. FMEA is not an added or separate engineering
activity but instead is a process for capturing and coordinating the thought process of engineers on how to
design, build, and provide a defect-free product. Steps to an effective FMEA include:
 Definition of the form, fit, and functional requirements of a product or process from engineering,
reliability, quality, and customer requirements and specifications.
 Identification of known and potential failure modes.
 Identification of root causes and effects of each failure mode.
 Prioritization of risks based upon ratings of probability of occurrence and expected impact for
each failure cause and effect. Detection is used as a third risk metric that identifies probability of
defect recognition and/or stage of recognition.
 Assignment of actions to avoid sources of failure or modify their impacts, reduce uncertainty or
plan reactive responses.
 Development of the product verification plan or process control plan and the approved parts list
are outcomes of a good FMEA. Additional outcomes are in-depth investigation of high risk failure
modes using root cause tools, cost/benefit analysis, and inputs to the risk management plan or
critical items control plan.
 Continuous management through monitoring, controlling, and reporting of risk action plans.

Benefits
 Establishes an effective risk management environment that impacts cost, schedule, and customer
satisfaction.
 Focuses fixed resources on mitigation of the highest risk areas.
 Enables actionable plans for risk mitigation and warranty cost reduction based upon failure causes.
 Protects against sub-optimization of the final risk management approach. Optimizes product
verification plans and process control plans by coordinating inputs from all disciplines,
organizations, and suppliers.
 Documents the engineering thought process and rationale, improves communication, captures
corporate knowledge, and motivates the development of appropriate data for effective risk
management.

Limitations
 Does not provide the answer and may leave the team with more questions than answers but
provides direction for other risk reduction approaches and activities.
 Efficient FMEA construction requires the careful selection and clear definition of scope, efficient
combination of pre-work and team meetings, well-defined process guidance and/or experienced
team leaders.
 FMEA is a bottoms-up approach that requires detailed drawings and specifications whereas Fault
Tree Analysis (FTA) is a tops-down approach that may be more suitable when information is

ESTC Product Reliability & Test Team

 limited to system schematics or basic functions and in describing complex events involving
multiple failures.

Implementation Strategy
An FMEA is most effective when it focuses on new hardware, functions, or applications that require
management of uncertainty. When the system, design, product, process, or service is evolutionary, the
scope of the FMEA can be adjusted to focus resources on areas of uncertainty. Starting with a well-defined
and bounded scope increases the efficiency of the team and provides early successes. FMEAs on
components, subassemblies, or subsystems can be readily combined when a consistent set of risk
prioritization definitions are applied.

Three types of FMEA commonly applied are the System FMEA, the Design FMEA, and the Process
FMEA.
Table 1. Types of FMEAs
Type of FMEA Objective
System Validate that the system design
specifications minimize the risk of
functional failure during operation
Design Identify and prevent product failures that
are related to the design
Process Identify and prevent failures related to the
manufacturing or assembly process for a
specific component/subassembly
Timing
After system functions are defined but
usually before specific hardware is
selected.
Update from field usage.
Initiate after the product functions are
defined but before the design is approved
for prototype tests.
Update for the detailed design and with
field usage.
Initiate when the preliminary drawings of
the product are available and the process
flow is developed.
Update from prototype testing and field
usage.

The FMEA team should contain members with the following capabilities:
 Experience or expertise in the design or process being assessed (designer, manufacturing, and
procurement engineers).
 FMEA facilitation and/or leadership skills
 Expertise in end-customer needs or satisfaction level (marketing and quality engineer)
 Teamwork skills

Resources
The resources required to construct an FMEA are assembled within the Product Reliability web site at
http://estc.corp.hp.com/reliability/Risk_Reduction/fmea.asp . Topics include:
 Guidance in FMEA roles and responsibilities, preparation, and construction in an HP document
from the Workforce Development Team.
 FAQ on FMEA from HP engineers.
 References for FMEA texts, training, software tools, and supporting data sources.

ESTC Product Reliability & Test Team